Letrozole

Product NDC
24979-726
11-digit product format
249790726
Labeler code
24979
Product ID
24979-726_4d5cb59c-11c3-4b0d-e063-6294a90a5b87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA205869
Marketing category
ANDA
Marketing start
2025-01-10
Substance
LETROZOLE
Active strength
2.5 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Letrozole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LETROZOLE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LKK855W8I
Rxcui200064

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d50ad188-a2a9-1aec-5d6c-f8612e9e5867Product name420190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-726-07Letrozole90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-726-06EA - Each24979-726d5e614c5-ab93-48ee-8341-2695c0fe3d6d12025-03-04
24979-726-07EA - Each24979-72605d3bbd4-6604-4cbb-ab3d-e98ff3ed36e412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-726LETROZOLE (LETROZOLE TABLETS) TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]2Current NDC, 1 package rows20250112_2d1f18f0-2c77-407c-b702-2d1b07f92510.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN2d1f18f0-2c77-407c-b702-2d1b07f925103
200064letrozole 2.5 MG Oral TabletSCD2d1f18f0-2c77-407c-b702-2d1b07f925103
200064letrozole 2.5 MG Oral TabletPSN32d7dd83-a3ef-41fe-e063-6394a90ae62a2
200064letrozole 2.5 MG Oral TabletSCD32d7dd83-a3ef-41fe-e063-6394a90ae62a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-726-072497907260790 TABLET, FILM COATED in 1 BOTTLE (24979-726-07) 2025-01-10NoNoCurrent